Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population

NCT00207935 | Completed Phase 4

• 1 other identifier: CNMC IRB 3579
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if children with learning problems can learn how to swallow pills without chewing them. The reason this is important is that if a person has seizures, medications must be taken every day. Most medications need to be taken 2 or 3 times per day. Some medications have slow release and only are taaken once per day. Medications with slow release usually come in capsule form and cannot be opened or chewed. This study investiates whether children with developmental delay can be taught how to swalow pills.

Conditions

Epilepsy; Mental Retardation; Developmental Disabilities

Keywords

Seizures; Depakote; Developmental Delay; Mental Retardation; Swallow

Outcome Measures

Primary Outcomes (1)

• Ability to swallow capsules in a mentally retarted developmentally delayed population

Interventions

Swallow instruction BEHAVIORAL

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 4-18 years, inclusive.
• Clinical Diagnosis of Partial or Primary Generalized Seizure Disorder
• Documented IQ scores in the range of borderline, mild, moderate, or severe mental retardation (IQ\<80).
• Currently Treatment regimen includes Depakote® Sprinkles either as monotherapy or adjunctive therapy. Dosages should have been stable for at least 4 weeks prior to baseline.
• Subject's parent or guardian must be capable of maintaining a record of dosing times, seizure characteristics, and adverse events.

You may not qualify if:

• Oral Motor Dysfunction to the degree that swallowing is affected.
• History of significant aspiration.
• Serious medical conditions such as cancer, pancreatitis, diabetes, HIV.
• History of hepatic dysfunction including history of elevated liver enzymes (AST or ALT values greater or equal to three times the upper limit of normal).
• History of metabolic disorders including urea cycle disorders.
• Pregnancy

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Epilepsy; Intellectual Disability; Developmental Disabilities; Seizures; Learning Disabilities

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders

Study Officials

• Joan A Conry, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2005
• Study Completion: March 1, 2007
• Last Updated: May 5, 2008

Record last verified: 2005-09

Locations

US (1)